Erectile Function
Conditions
Brief summary
The objective of this study is to see whether a home-use penile constriction device, Firmtech Tech Ring, can be determined to be superior to the Giddy device through evaluation of Leikert scale scores to assess ease of use and participant comfort and satisfaction with erectile quality with these devices. The primary outcome will be the satisfaction with use of the device as assessed through the Leikert scores. The other outcomes will be secondary.
Interventions
OTHERFirmTech Tech Ring
Participants will utilize the FirmTech Tech Ring at least twice during a two-week time period and complete a survey
OTHERGiddy Penile Constriction Ring
Participants will utilize the Giddy Penile Constriction at least twice during a two-week time period and complete a survey
Sponsors
FirmTech, Inc.
Reproductive Medicine Associates of New Jersey
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* All English-speaking participants \> 18 years old recruited through social media. * Physically and emotionally capable of engaging in sexual activity with at least one attempt per week of masturbation or sexual intercourse
Exclusion criteria
* Men who cannot understand English. * Men with a prior or current penile implant. * Transgender or non-binary individuals * Men diagnosed with a hidden or buried penis. * Investigator's impression of expected poor participant compliance or anatomic inadequacy (penile size/girth) * Any psychiatric disorder, which, in the opinion of the investigator, would prohibit participation. * Coagulopathy or other blood disorder which the investigator determines would affect the participant's participation in the trial. * Any tumor in the pelvic or penile region within the last 3 years * Men with an active caregiver who are unable to live independently. * Men who the provider is concerned would be at high risk for non-healing wounds of the penis. * Participants with sensory disorders like sensory processing disorder, sensory integration dysfunction disorder, neuropathies, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device satisfaction via Leikert scores | 2 weeks after receiving device | A survey will be completed for each device after utilization |
Countries
United States
Outcome results
None listed